# K090175: Unity Beta Plla System

- Pathway: 510(k) (Traditional)
- Applicant: Bonutti Research, Inc.
- Decided: Sep 10, 2009 after 230 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bonutti Research, Inc., electrical generators and ultrasonic handpieces used in sutureless fixation: named in the summary without a submission number

## Most influential descendants
- K131984: Synthes Synsonic Ulna Nail (2014), 0 descendants of its own

## Indications for use
The Unity Ultrasonic System consists of an electrical generator and ultrasonic handpiece. The system is to be used with existing Unity Alpha single patient use absorbable (PLLA) implants intended for use as fasteners (anchors) in the fixation of tissue, ligament, tendon, and bone. The system is indicated in general soft tissue approximation/ligation.

Source page: https://510kreport.com/device/K090175
Methodology: https://510kreport.com/methodology